Baseline Pain Levels Research Articles

Defining patient acceptable symptom state thresholds for commonly used patient reported outcomes measures in general orthopedic practice

BackgroundPatient reported outcomes measures are distributed regularly within musculoskeletal physical therapy practice in an effort to track patient progress and response to treatment. A number of studies have reported on the amount of change necessary to identify the minimal clinically important difference. Few studies have identified thresholds signifying patient satisfaction with treatment and what patient specific factors may be influential in identifying patient satisfaction. ObjectivesTo identify thresholds amongst commonly used patient reported outcomes measures associated with the patient acceptable symptom state (PASS). To identify the confounding effects of demographic and psychosocial variables on reported PASS estimates. DesignProspective cohort study. MethodA sample of convenience consisting of consecutive patients referred for outpatient physical therapy for general orthopaedic conditions fulfilling the eligibility criteria were included. All patients completed baseline demographic information as well as baseline pain and functional outcomes measures. The PASS question was used as the anchor in this study to identify patient thresholds. Patients completed outcomes measures every 2 weeks and at patient discharge. PASS thresholds were identified using receiver-operating curves maximizing sensitivity and specificity. ResultsPASS thresholds were found to vary depending on baseline pain levels, functional status, socioeconomic status, educational level, and psychosocial status. ConclusionsMultiple factors are influential in determining patient success following treatment. Clinicians should be aware of patient baseline pain and functional status as well as socioeconomic status, educational level, and psychosocial status and stratify patients accordingly when determining patient prognosis and developing a plan of care.

The relationship between preoperative general mental health and postoperative quality of life in minimally invasive lumbar spine surgery.

In assessing poor lumbar surgery outcomes, researchers continue to investigate psychosocial predictors of patient postoperative quality of life. This is the first study of its kind to investigate this relationship in an exclusively minimally invasive patient sample. To determine the association between preoperative mental health and postoperative patient-centered outcomes in patients undergoing minimally invasive lumbar surgery. In 83 adults undergoing single-level minimally invasive lumbar spine surgery, Pearson correlation and partial correlation analyses were conducted between all demographic and clinical baseline variables and Oswestry Disability Index (ODI), Visual Analogue Scale (VAS), and 36-item Short-Form Health Survey Version 2.0 (SF-36v2) scores at 6 to 12 months postoperatively. SF-36v2 mental component summary scores (MCS) were used to assess pre- and postoperative general mental health. Post hoc analysis consisted of Pearson correlations between baseline SF-36v2, ODI, and VAS scores, and an identical set of correlations at outcomes. Preoperative MCS showed no significant association with outcomes VAS, ODI, or physical component summary scores. Baseline disability correlated significantly and more strongly with baseline MCS (P < .001, r = -0.40) than baseline pain levels (VAS back not significant, VAS leg P = .015, r = 0.27). Outcomes disability correlated significantly and more strongly with outcome back and leg pain levels (P < .001, r = 0.60 and 0.66) than outcome MCS (P = .031, r = -0.24). In a patient sample with mental health scores comparable to the population mean, there is no relationship between preoperative general mental health and postoperative patient-centered outcomes. Surgeons should consider the dynamic relationships between patient disability, mental health, and pain levels in assessing quality of life at different time points.

The relationship between chief complaint and comparable sign in patients with spinal pain: An exploratory study

Many musculoskeletal management philosophies advocate the exploration of the relationship between the patient's chief complaint (CC) and the physical examination findings that reproduce/reduce/change that CC. Geoffrey Maitland developed the concept “comparable sign(s) (CS), which are physical examination findings related to the CC(s) that are reproduced during an examination/treatment. These include observed abnormalities of movement, postures or motor control, abnormal responses to movement, static deformities, and abnormal joint assessment findings. There are no studies that have explored the potential clinical relationships between the patient's CC and a CS, thus this exploratory study evaluated the associations, outcomes, and prevalence of the findings. This cohort study involved 112 subjects age 54.3 years (SD = 13.4 years), with neck (25.9%) or low back pain (74.1%) who were treated with physiotherapy for an average of 42 days. Data analysis revealed 88.4% identified a CC at baseline. There was a moderate statistical association between CC and the active physiological finding of a CS (r = 0.36), and small-moderate associations between all examination phases (r = 0.25–0.37). There were no statistical differences in pain and disability outcomes for those with and without a CC or CS; however, baseline pain levels were higher for those without CC (p = 0.04). Further, rate of recovery was lower in those without a CS during passive physiological examination. The results would suggest that there may be content validity to the concept of CS but further research with larger samples sizes is required to explore the extent of the validity is warranted.

The Subjective Psychoactive Effects of Oral Dronabinol Studied in a Randomized, Controlled Crossover Clinical Trial for Pain

Many cannabinoid medications are approved in North America or in phase III trials, such as dronabinol, nabilone, or nabiximols. Little is known about their subjective psychoactive effects when used for pain management. We hypothesized that when used for pain, dronabinol has psychoactive effects in a dose-response relationship, whose peak effects are comparable with smoking marijuana. This was a randomized controlled trial of single dose placebo, 10 or 20 mg dronabinol in 30 chronic noncancer pain patients taking opioids and not using marijuana. Participants completed the Addiction Research Center Inventory (ARCI) hourly for 8 hours during 3 monitored sessions. Comparison sample was the ARCI ratings in participants with no pain (N=20), monitored every 30 minutes after smoking a 1.99% THC (low) and a 3.51% (high strength) marijuana cigarette. The 10 and 20 mg dronabinol doses had significantly elevated scores over time on 4/5 subscales versus placebo (P<0.05). Average daily morphine use, total pain relief (TOTPAR), age, sex, and baseline pain level were not significant covariates. ARCI peak effects at 2 hours were similar to peak effects of smoked marijuana at 30 minutes (P=0.80, 10 mg=low strength, 20 mg=high strength). In pain patients, oral dronabinol has similar psychoactive effects to smoking marijuana. This risk must be considered in any decision to prescribe cannabinoid medications for pain.

Effect of variability in the 7-day baseline pain diary on the assay sensitivity of neuropathic pain randomized clinical trials: An ACTTION study

The degree of variability in the patient baseline 7-day diary of pain ratings has been hypothesized to have a potential effect on the assay sensitivity of randomized clinical trials of pain therapies. To address this issue, we obtained clinical trial data from the Food and Drug Administration (FDA) through the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public–private partnership, and harmonized patient level data from 12 clinical trials (4 gabapentin and 8 pregabalin) in postherpetic neuralgia (PHN) and painful diabetic peripheral neuropathy (DPN). Models were developed using exploratory logistic regression to examine the interaction between available baseline factors and treatment (placebo vs active medication) in predicting patient response to therapy (ie, >30% improvement). Our analysis demonstrated an increased likelihood of response in the placebo-treated group for patients with a higher standard deviation in the baseline 7-day diary without affecting the likelihood of a response in the active medication–treated group, confirming our hypothesis. In addition, there was a small but significant age-by-treatment interaction in the PHN model, and small weight-by-treatment interaction in the DPN model. The patient’s sex, baseline pain level, and the study protocol had an effect only on the likelihood of response overall. Our results suggest the possibility that, at least in some disease processes, excluding patients with a highly variable baseline 7-day diary has the potential to improve the assay sensitivity of these analgesic clinical trials, although reductions of external validity must be considered when increasing the homogeneity of the investigated sample.

Infiltration of Bupivacaine Local Anesthetic to Trocar Insertion Sites After Laparoscopy: A Randomized, Double-blind, Stratified, and Controlled Trial

Study ObjectiveTo determine if injection of local anesthetic into trocar insertion sites after laparoscopy improves postoperative pain. DesignA prospective, 2-arm, randomized, double-blind, stratified, and controlled trial (Canadian Task Force classification I). SettingA university-based teaching hospital. PatientsThis study was performed on women who had a laparoscopic gynecologic procedure for benign indications from March 2013 to June 2013. One hundred thirty-five subjects were stratified by chronic pelvic pain or no chronic pelvic pain. Chronic pelvic pain was defined as pelvic pain occurring for 6 months or more in duration. Randomization was performed for this trial, with 68 receiving a bupivacaine block and 67 receiving no bupivacaine block. Of the 71 patients with chronic pelvic pain, 35 patients were in group 1 (i.e., bupivacaine block) and 36 patients were in group 2 (i.e., no bupivacaine block). InterventionsAfter the laparoscopic surgery was completed, the trocar incision sites were closed. For subjects randomized to receive a local anesthesia block, bupivacaine (0.25%) was injected. Incisions 8 mm or greater were injected with 10 mL 0.25% bupivacaine. Incisions 5 mm or less were infiltrated with 5 mL. Injecting the local anesthetic through all preperitoneal layers provided a full-thickness local injection. Group 2 did not receive a local injection. Measurements and Main ResultsAt the preoperative suite, the nurses gauged the patient's pain using the Numeric Rating Scale. This score was used as the baseline pain level with which the postoperative pain scores were compared. The primary objective was to measure changes in pain scores, from preoperative to postoperative time frames of 2 to 4 hours, 6 to 8 hours, 18 to 24 hours, and 3 to 7 days postoperatively. These score changes were measured as the main objective. Secondary objectives include estimated blood loss, operating time, length of hospital stay, and histopathologic diagnosis. The hospital personnel caring for the patient during the preoperative and postoperative course were given standard pain evaluation protocols. All study pain evaluators and patients were blinded to treatment assignments throughout the pain assessment process. There were no statistically significant differences in patient characteristics between the 2 treatment groups. No significant difference was found in secondary outcomes including estimated blood loss, length of hospital stay, and histopathologic diagnosis. In general, Numeric Rating Scale pain scores were lower (i.e., less pain) in the “bupivacaine block” group compared with the “no bupivacaine” block group at the following postsurgery time assessments: 2 to 4 hours, 6 to 8 hours, 18 to 24 hours, and 3 to 7 days after surgery. However, the effect was not large enough (<1 point) to show a statistical difference between the treatment groups at any of these postsurgery assessments. ConclusionThe postoperative injection of bupivacaine in trocar port sites did not significantly improve pain scores after laparoscopic gynecologic surgery.

Potential value of rapid prostate-specific antigen decline in identifying primary resistance to abiraterone acetate and enzalutamide.

To identify factors predicting primary resistance to new-generation hormonal agents (NHAs), abiraterone acetate and enzalutamide in patients with castration-resistant prostate cancer (CRPC). Our hospital has conducted two successive named patient NHA programs. A total of 57 patients with progressive CRPC previously treated with first-line docetaxel-based chemotherapy received standard NHA doses: abiraterone acetate 1000 mg once-daily combined with prednisone (5 mg twice daily) or enzalutamide 160 mg once-daily. Patients, who were assessed monthly to check their hematological parameters and prostate-specific antigen (PSA) levels, also underwent imaging investigations every 3-4 months. In total, 24 variables were assessed as potential predictors of primary NHA resistance. Univariate analysis indicated that baseline pain and lactate dehydrogenase levels, and PSA levels after 1 month's treatment were predictive of primary NHA resistance. Only the predictive value of PSA levels after 1 month of treatment was confirmed at multivariate analysis. This factor strongly predicted progression-free and overall survival. RESULTS suggest the use of a simple and rapid method of identifying patients with primary resistance to NHAs: patients not achieving a ≥ 50% reduction in PSA levels within the first treatment month should undergo intensive investigations to verify whether they have primary resistance to NHAs.

Determinants of Pain Severity Changes in Ambulatory Patients With Cancer: An Analysis From Eastern Cooperative Oncology Group Trial E2Z02

To understand changes in pain severity over time and to explore the factors associated with pain changes in ambulatory patients with solid tumors. We enrolled 3,106 patients with invasive cancer of the breast, prostate, colon/rectum, or lung from multiple sites. At baseline and 4 to 5 weeks later, patients rated their pain level on a 0 to 10 numerical rating scale. A 2-point change in pain score was defined as a clinically significant change in pain. Multivariable logistic models were fitted to examine the effects of pain management and demographic and clinical factors on change in pain severity. We analyzed 2,761 patients for changes in pain severity. At initial assessment, 53.0% had no pain, 23.5% had mild pain, 10.3% had moderate pain, and 13.2% had severe pain. Overall, one third of patients with initial pain had pain reduction within 1 month of follow-up, and one fifth had an increase, and the improvement and worsening of pain varied by baseline pain score. Of the patients without pain at initial assessment, 28.4% had pain (8.9% moderate to severe) at the follow-up assessment. Logistic regression analysis showed that inadequate pain management was significantly associated with pain deterioration, as were lower baseline pain level, younger age, and poor health status. One third of patients have pain improvement and one fifth experience pain deterioration within 1 month after initial assessment. Inadequate pain management, baseline pain severity, and certain patient demographic and disease characteristics are associated with pain deterioration.

Experimental and Psychological Pain Phenotyping In Adults With Sickle Cell Anemia and Normal Volunteers

IntroductionSickle cell anemia (SCA) is the most prevalent Mendelian disease in the U.S. and is characterized by HbS polymerization, hemolytic anemia and vaso-occlusion. The hallmark clinical manifestation of SCA is acute vaso-occlusive pain crisis (VOC) with severe episodes requiring hospitalization for pain management. Vaso-occlusion resulting in pain is believed to occur with hypoxia, intra-vascular erythrocyte sickling and ischemia reperfusion injury. Recurring episodes of VOC often have no clear causation and may have effects upon physiological pain perception and intrinsic psychological characteristics like catastrophizing. It is not presently known if physiological pain processing or psychological factors influence pain in SCA compared to normal volunteers (NV). We hypothesized that adults with SCA would experience hypersensitivity to painful stimuli compared to NV as seen in other chronic painful conditions. Methods18 subjects with SCA and 19 age and sex matched NV underwent quantitative sensory testing (QST) for thermal, pressure and ischemic experimental pain phenotypes. Thermal testing (cold and heat) was performed at 4 sites on the volar forearm for temperature at first detection, threshold for sensing pain, and pain tolerance. Pressure pain threshold and tolerance were measured bilaterally at the thumb, forearm, and trapezius with an algometer. Ischemic pain testing was performed on the non-dominant arm inflating a blood pressure cuff of 220 mmHg and determining time to threshold and tolerance. Subjects were also administered the Pain Catastrophizing Scale (PCS-E) which is composed of 13 questions that address 3 dimensions: rumination, magnification, and helplessness. SCA and NV subjects with chronic pain unrelated to complications of SCA were excluded. All SCA subjects tested at baseline pain levels at least 2 weeks since their last painful event requiring intravenous narcotics. Non-parametric t-tests were used to compare results between SCA subjects and NV. ResultsThe mean age of SCA subjects was 33.4 (range 21-47) and NV was 32.1 (range 18-44). The only significant difference for thermal QST was temperature at first cold detection (SCA mean 24.5±6.3 ¢ªC vs. NV mean of 26.6±4.7 ¢ªC, P=0.05). There were no other significant thermal differences between SCA subjects and NV for cold pain threshold (P=0.84), cold pain tolerance (P=0.82), first heat detection (P=0.21), heat pain threshold (P=0.68) or heat pain tolerance (P=0.38). Furthermore, there were no differences in pressure between SCA and NV for pain thresholds at the thumb (P=0.31), forearm (P=0.44) or trapezius (P=0.10), nor were there pain tolerance differences at the thumb (P=0.63), forearm (P0.98) or trapezius (P=0.44). Surprisingly, ischemic pain QST showed no differences for initial pain threshold (468.3±263.1 seconds for SCA vs. 569.6±395.8 seconds for NV, P=0.69) or pain tolerance (642.5±245.4 seconds for SCA vs. 774.4±453.5 seconds for NV). Compared to NV, SCA subjects had significantly higher total catastrophizing (SCA median 30 vs. NV median 7, P=0.0005), rumination (SCA median 12 vs. NV median 3, P=0.0038), magnification (SCA median 8 vs. NV median 3, P=0.0006), and helplessness scores (SCA median 13 vs. NV median 3, P=0.0004). ConclusionsThermal detection of cold temperature change was the only observed difference, despite our hypothesis that recurrent painful episodes from SCA would alter sensitivity to experimental stimuli. Of particular interest are the results of ischemic pain QST, where SCA subjects appear to tolerate ischemia as well as NV despite the expectation this test would promote earlier forearm hypoxia, erythrocyte sickling and potentially vaso-occlusion. No significant difference in onset of ischemic pain between SCA and NV subjects appears to contradict the predominant pain vaso-occlusion paradigm for SCA. In addition, SCA subjects report significant levels of pain castastrophizing. Catastrophizing in other pain conditions may contribute to a psychological state that increases the severity of pain perception and a fear that pain control is impossible. Thus, catastrophizing may enhance chronic pain, pain impact, and its refractory response to pharmacotherapy. Further studies are necessary to determine if experimental pain or catastrophizing are associated with acute pain or chronic pain in SCA and to further elucidate the pathophysiology of pain in SCA. Disclosures:No relevant conflicts of interest to declare.

Long-term result and patient reported outcome of wrist splint treatment for Carpal Tunnel Syndrome

Carpal tunnel syndrome (CTS) is the commonest peripheral neuropathy presenting to specialist hand and wrist clinics. This study investigated the long-term outcome of carpal tunnel syndrome treated with isolated night wrist splint and the factors determining the likelihood of success of this intervention. Seventy-five patients referred to a specialist hand clinic with CTS were given night wrist splint treatment for 3 months as per a previous study protocol. Fifty-two patients from this cohort did not wish to have surgery after wrist splint treatment and were followed for a further 33-month period. Baseline pain and numbness levels were recorded on a Visual Analogue Scale (VAS) using a questionnaire upon first presentation. A further questionnaire at 36 months reassessed pain and numbness levels, patients' satisfaction with the treatment, and whether they had subsequent surgical decompression. Of the patients who completed the follow-up questionnaire 33 months after their period of conservative management, 43% were successfully treated with splint treatment alone. There was no difference in the VAS for pain or numbness at the baseline and at 36 months between successful and failed treatment groups. Patients successfully treated with wrist splinting alone reported a higher level of satisfaction with their treatment compared to patients who failed wrist splint treatment or had surgical decompression. The results reinforce the previous recommendation on wrist splinting as a first-line treatment in the Primary Care setting. Referral to specialist hand and wrist clinics should be reserved for patients with symptoms refractory to this initial measure.

Musculoskeletal pain and physical functioning in the oldest old

Little is known about the impact of pain on physical functioning among the oldest-old subjects. In this study, we first examined the associations between the number of painful sites and measures of physical functioning reflecting different stages of the disablement process (physical impairment, functional limitation and disability) among nonagenarians (more than ninety years old persons). Second, we described the effect of painful sites on disability during a 2-year follow-up period. This study is based on baseline (n = 1177) and 2-year follow-up (n = 709) data of the nationwide Danish 1905 cohort study. Musculoskeletal pain was assessed as reported pain in back, hips or knees when moving or resting. Physical performance measures included maximum grip strength and habitual walking speed. Disability in performing activities of daily living was defined as the need for assistive device or personal help in transferring, dressing, washing, using toilet and/or walking indoors. At baseline, the number of painful sites was significantly associated with measured grip strength and walking speed as well as self-reported disability in a stepwise manner; the more sites with pain, the poorer the physical functioning. The follow-up analyses showed corresponding but slightly weaker stepwise associations between baseline pain and disability level at follow-up, and indicated that although on the whole, single or multi-site pain did not predict the onset of disability, multi-site pain increased the risk of developing severe disability. The findings of this study suggest that musculoskeletal pain in nonagenarians is highly prevalent and is associated with poor physical performance and disability.

Management of acute whiplash: A randomized controlled trial of multidisciplinary stratified treatments

Acute whiplash is a heterogeneous disorder that becomes persistent in 40% to 60% of cases. Estimates of recovery have not changed in recent decades. This randomized, single-blind, controlled trial tested whether multidisciplinary individualized treatments for patients with acute whiplash (<4weeks postinjury) could reduce the incidence of chronicity at 6mo by 50% compared to usual care. Participants (n=101) were recruited from accident and emergency centres and the community. It was hypothesized that better recovery rates were achievable if the heterogeneity was recognised and patients received individualised interventions. Patients randomized to pragmatic intervention (n=49) could receive pharmaceutical management (ranging from simple medications to opioid analgesia), multimodal physiotherapy and psychology for post-traumatic stress according to their presentations. The treatment period was 10wks with follow-up at 11weeks and 6 and 12-months. The primary outcome was neck pain and disability (Neck Disability Index (NDI)). Analysis revealed no significant differences in frequency of recovery (NDI ⩽8%) between pragmatic and usual care groups at 6months (OR 95%, CI=0.55, 0.23–1.29), P=0.163) or 12mo (OR 95%, CI=0.65, 0.28–1.47, P=0.297). There was no improvement in current nonrecovery rates at 6mo (63.6%, pragmatic care; 48.8%, usual care), indicating no advantage of the early multiprofessional intervention. Baseline levels of pain and disability had a significant bearing on recovery both at 6 and 12mo in both groups, suggesting that future research focus on finding early effective pain management, particularly for the subgroup of patients with initial high levels of pain and disability, towards improving recovery rates.

A comprehensive approach in hospice shared care in Taiwan: Nonelderly patients have more physical, psychosocial and spiritual suffering

While symptomatic differences exist between younger and older advanced cancer patients, few studies have examined the differences in their care with respect to age. Our goals were to examine the influences of age differences on physical, psychosocial and spiritual distress among advanced cancer patients. Advanced cancer patients who resided in Kaohsiung Medical University Hospital during 2007–2008 were recruited. Data were collected through professional consultants. The influences of age variations on physical, psychosocial and spiritual distress in nonelderly (<60 years old) and elderly (≧60 years old) patients were analyzed. A total of 1013 advanced cancer patients were included in the analyses with 467 nonelderly patients and 546 elderly patients. Nonelderly patients were identified to have a higher baseline pain level (4.0 vs. 2.8, p<0.001), breakthrough pain (19.3% vs. 9.9%, p<0.01), insomnia (6.4% vs. 2.7%, p=0.006), emotional distress (69.0% vs. 60.6%, p=0.013), and unwillingness to pass away because of concern for loved ones (18.8% vs. 11.9%, p=0.003) with significant difference. Elderly ones were concerned about unfulfilled wishes (29.7% vs. 18.4%, p<0.001) in spiritual concerns. After adjustments in regression models, nonelderly age (<60 years old) still revealed significant positive or negative impact on all categories of distress. Patients aged under 60 years have more physical, psychosocial and spiritual suffering. This study suggested that professional practitioners should provide intensive care for vulnerable terminally ill cancer patients.

Natural course of acute neck and low back pain in the general population: The HUNT study

In this prospective cohort study we aimed to describe the natural course of acute neck and low back pain in a general population of Norway. We screened 9056 subjects aged 20–67years who participated in a general health survey for a new episode of neck or low back pain the previous month. The screening identified 219 subjects who formed the cohort for this study. Pain intensity was reported on a numeric rating scale (0–10) at 1, 2, 3, 6, and 12months after start of the new pain episode. The course of pain was described for neck and low back pain, different baseline pain levels, age groups, and number of pain sites at baseline. Use of medication and health care was described and associations between pain intensity and seeking health care were estimated. Pain declined rapidly within 1month after a new pain episode, with a reduction of 0.91 (95% confidence interval [CI] 0.50–1.32) for neck pain and 1.40 (95% CI 0.82–1.99) for low back pain with little change thereafter. However, pain remained unchanged over the follow-up year for those with equal pain in the neck and low back areas at baseline and for those reporting 4 or more pain sites at baseline. Only 1 in 5 sought health care for their complaints. Still, the course of pain was comparable to effect sizes reported in interventional studies. This study thus contributes natural course reference data for comparisons of pain outcome in clinical trials and practice.

Gabapentin reduces preoperative anxiety and pain catastrophizing in highly anxious patients prior to major surgery: a blinded randomized placebo-controlled trial

Gabapentin is increasingly being used for the treatment of postoperative pain and a variety of psychiatric diseases, including chronic anxiety disorders. Trials have reported mixed results when gabapentin has been administered for the treatment of preoperative anxiety. We tested the hypothesis that gabapentin 1,200 mg vs placebo would reduce preoperative anxiety in patients who exhibit moderate to high preoperative anxiety. A blinded randomized controlled trial was conducted from September 2009 to June 2011 at the Toronto General Hospital. Following ethics approval and informed consent, 50 female patients with a 0-10 numeric rating scale (NRS) anxiety score of greater than or equal to 5/10 consented to receive either gabapentin 1,200 mg (n = 25) or placebo (n = 25) prior to surgery. Randomization was computer generated, and the Investigational Pharmacy was responsible for the blinding and dispensing of medication. All patients and care providers, including physicians, nurses, and study personnel, were blinded to group allocation. Before administering the study medication, baseline anxiety levels were measured using a NRS, the Spielberger State-Trait Anxiety Inventories, the Pain Catastrophizing Scale, and the Pain Anxiety Symptoms Scale-20. Baseline pain intensity (0-10 NRS) and level of sedation (0-10 NRS and Richmond Agitation-Sedation Scale [RASS]) were also measured. Two hours after the administration of gabapentin or placebo (prior to surgery), patients again rated their anxiety, pain, and sedation levels using the same measurement tools as at baseline. The main outcome was a reduction in preoperative anxiety. Forty-four patients (22 treated with gabapentin 1,200 mg and 22 treated with placebo) were included in the analysis of the primary outcome. Analysis of covariance in which pre-drug NRS anxiety scores were used as the covariate showed that post-drug preoperative NRS anxiety (Effect size, 1.44; confidence interval [CI] 0.19 to 2.70) and pain catastrophizing (Effect size, 0.43; CI 0.12 to 0.74) scores were significantly lower in the gabapentin group than in the placebo control group, respectively. Post-drug sedation (Effect size, -3.02; CI -4.28 to -1.77) and RASS (Effect size, 0.41; CI 0.12 to 0.71) scores were significantly higher in the gabapentin group than in the placebo group, respectively. Administration of gabapentin 1,200 mg prior to surgery reduces preoperative NRS anxiety scores and pain catastrophizing scores and increases sedation prior to entering the operating room. These results suggest that gabapentin 1,200 mg may be a treatment option for patients who exhibit high levels of preoperative anxiety and pain catastrophizing; however, the sedative properties of the medication and the possibility of delayed postoperative discharge in the elective ambulatory population need to be considered.

Gender differences in pain levels before and after treatment: a prospective outcomes study on 3,900 Swiss patients with musculoskeletal complaints

BackgroundCurrent studies comparing musculoskeletal pain levels between the genders focus on a single point in time rather than measuring change over time. The purpose of this study is to compare pain levels between males and females before and after treatment.MethodsEleven different patient cohorts (3,900 patients) included in two prospective outcome databases collected pain data at baseline and 1 month after treatment. Treatments were either imaging-guided therapeutic injections or chiropractic therapy. The Mann–Whitney U test was used to calculate differences in numerical rating scale (NRS) median scores between the genders for both time points in all 11 cohorts.ResultsFemales reported significantly higher baseline pain scores at 4 of the 11 sites evaluated (glenohumeral (p = 0.015), subacromial (p = 0.002), knee (p = 0.023) injections sites and chiropractic low back pain (LBP) patients (p = 0.041)). However, at 1 month after treatment there were no significant gender differences in pain scores at any of the extremity sites. Only the chiropractic LBP patients continued to show higher pain levels in females at 1 month.ConclusionsIn these 11 musculoskeletal sites evaluated before and after treatment, only 3 extremity sites and the chiropractic LBP patients showed significantly higher baseline pain levels in females. At 1 month after treatment only the LBP patients had significant gender differences in pain levels. Gender evaluation of change in pain over time is likely to be more clinically important than an isolated pain measurement for certain anatomical sites.

Bone-Related Complications and Quality of Life in Advanced Breast Cancer: Results from a Randomized Phase III Trial of Denosumab versus Zoledronic Acid

Denosumab was shown to be superior to zoledronic acid in preventing skeletal related events (SRE) in patients with breast cancer and bone metastases in a randomized, double-blind phase III study. We evaluated further results from this study related to skeletal complications and health-related quality of life (HRQoL). Patients were randomized 1:1 to receive subcutaneous denosumab 120 mg (n = 1,026) and intravenous placebo, or intravenous zoledronic acid 4 mg (n = 1,020) and subcutaneous placebo every 4 weeks. Analyses reported here include the proportion of patients with one or multiple on-study SREs, time to first radiation to bone, time to first SRE or hypercalcemia of malignancy, and change in HRQoL (functional assessment of cancer therapy-general). Fewer patients receiving denosumab than zoledronic acid had an on-study SRE (31% vs. 36%, P = 0.006). The incidence of first radiation to bone was 12% (n = 123) with denosumab versus 16% (n = 162) with zoledronic acid. Denosumab prolonged the time to first radiation to bone by 26% versus zoledronic acid (HR, 0.74; 95% confidence interval [CI], 0.59-0.94, P = 0.012) and prolonged the time to first SRE or hypercalcemia of malignancy by 18% (HR, 0.82; 95% CI, 0.70-0.95; P = 0.007). Ten percent more patients had a clinically meaningful improvement in HRQoL with denosumab relative to zoledronic acid, regardless of baseline pain levels. Denosumab was superior to zoledronic acid in reducing bone-related complications of metastatic breast cancer and maintained HRQoL, providing an efficacious, well-tolerated treatment option for patients with bone metastases from breast cancer.

An assessment of the efficacy and safety of diclofenac potassium liquid-filled capsules in patients with various levels of baseline pain intensity

Context:Diclofenac potassium liquid-filled soft gelatin capsule (DPSGC; Zipsor) is a novel formulation of diclofenac potassium used to treat mild to moderate acute pain.Objective:To investigate whether DPSGC 25 mg provided significant reduction in pain intensity compared with placebo, regardless of baseline pain intensity, a post hoc analysis was performed of pooled data from two replicate randomized controlled trials (NCT00366444 and NCT00375934) that evaluated the safety and efficacy of DPSGC in postbunionectomy treatment.Methods:Patients from the two randomized trials were assigned to one of two subgroups: patients with baseline numerical pain rating scale (NPRS) scores of 4 or greater to less than 7 and those with baseline NPRS scores of 7 or greater. Within each subgroup, efficacy and safety of DPSGC was compared with placebo.Results:Across the two studies, 73 DPSGC- and 59 placebo-treated patients had baseline pain intensity scores ranging from 4 or greater to less than 7, while 128 DPSGC- and 141 placebo-treated patients had baseline pain intensity scores of 7 or greater. Significantly lower mean 48-hour NPRS scores were observed in the DPSGC group, regardless of baseline pain intensity (P < 0.0001). In both subgroups, at least twice as many patients treated with DPSGC rated the study drug as very good or excellent compared with patients taking placebo. Potential limitations for this post hoc analysis include study design and patient population. As with all studies investigating treatment for pain, the use of rescue medication may also be a potential limitation.Conclusions:DPSGC provided significantly greater improvements in pain compared with placebo following bunionectomy, regardless of patients’ baseline pain level.

Effect of denosumab versus zoledronic acid on health-related quality of life in patients with metastatic breast cancer.

272 Background: Patients with breast cancer and bone metastases often experience skeletal-related events (SREs) and pain, which can impact health-related quality of life (HRQoL). Denosumab is superior to zoledronic acid (ZA) in preventing SREs and more effective in delaying moderate or severe pain in patients with advanced breast cancer. We now describe the effect of denosumab or ZA treatment on HRQoL in these patients. Methods: Patients enrolled in this double-blind, double-dummy study were randomized to receive denosumab (120 mg SC) or ZA (4 mg IV) every 4 weeks. Patients completed the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire at baseline (BL), day 8, and each monthly visit to assess overall HRQoL. Higher scores (range 0 to 108) reflect a better HRQoL. Changes in HRQoL were summarized through month 18, when 30% of patients had died or dropped out due to disease progression or withdrawal of consent. Increases or decreases of ≥ 5 points in the FACT-G total score were considered clinically meaningful. Pain was evaluated by the Brief Pain Inventory–Short Form (BPI-SF). HRQoL was assessed in subgroups with no/mild pain or moderate/severe pain at BL. Results: The BL mean (SD) FACT-G score was similar for denosumab (n = 956) 72.7 (16.4) and ZA (n = 952) 73.6 (16.5) groups and increased from BL to month18 for both groups reflecting improved HRQoL. An average of 3.2% more (range 0.9% to 6.8%) denosumab-treated patients than ZA-treated patients experienced a ≥ 5-point increase in HRQoL from months 1 to 18. Fewer denosumab than ZA-treated patients reported a ≥ 5-point decrease in HRQoL (average 2.7% fewer; range 0.6% to 5.8%). Among patients with no/mild pain at BL, an average of 4.1% more (range -0.6% to 9.3%) denosumab-treated patients had a ≥ 5-point increase in FACT-G score from month 4 to 18. In this same subgroup, fewer denosumab-treated patients had a ≥ 5-point decrease in HRQoL over 18 months (average 2.4% fewer; range -4.4% to 6.3%). Similar patterns in FACT-G scores were noted for the subgroup with moderate/severe pain at BL. Conclusions: In patients with advanced breast cancer, a greater proportion treated with denosumab than ZA had a meaningful improvement in HRQoL regardless of BL pain level.

Provocative lumbar discography versus functional anesthetic discography: a comparison of the results of two different diagnostic techniques in 52 patients with chronic low back pain

There is mounting evidence that the currently available techniques for the diagnosis of discogenic low back pain are insufficiently accurate-this may explain some of the variability in outcomes of surgery for this important clinical problem. New diagnostic methods are needed to address this diagnostic issue; improvements here may do as much to improve overall patient outcomes as improvements in surgical treatment methods. To compare the results of standard pressure-controlled provocative discography (PD) to those of the functional anesthetic discogram (FAD) in a series of patients presenting with chronic low back pain and considering surgical treatment. Prospective clinical series in an academic spinal surgical practice. Fifty-two patients presenting with chronic low back pain; mean age 45 years (range, 24-70 years); 28 women, 24 men; and 25% in workman's compensation program. Oswestry, visual analog scale for back pain, distress and risk assessment method psychometric analysis, demographic data, magnetic resonance imaging scan of lumbar spine. During provocative discogram: pressurization at pain, pain level, and concordancy. During FAD: position or activity used to elicit typical pain, baseline pain level before injection, during injection, at 5, 10, and 20 minutes after the injection, and substance injected. Standard pressure-controlled PD was performed, followed by (in positive cases or in patients with clinical features and imaging studies felt to be highly suggestive of symptomatic disc degeneration) the FAD test-an assessment of the response to injection of a low dose of local anesthetic into the disc during a position productive of the patient's typical pain. Discordant results of the two tests were noted in 46% of the patients in the series. Of them, 26% of patients with positive PD had negative findings on the FAD test; 16% had positive findings at a single level only, whereas the provocative discogram had been positive at two or more levels; 4% had new positive findings on the FAD test. We have presented the results of a new diagnostic technique in 52 patients with chronic low back pain presumed discogenic in origin that was designed to help differentiate between symptomatic and asymptomatic disc degeneration. The findings of the test differed from those of standard pressure-controlled PD in 46% of the cases reported on here. Further studies are needed to demonstrate the clinical utility of the test.